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VASOTEC Drug Profile
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When do Vasotec patents expire, and what generic alternatives are available?
Vasotec is a drug marketed by Biovail Labs Intl and Bausch and is included in two NDAs.
The generic ingredient in VASOTEC is enalapril maleate. There are twenty-seven drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.
US ANDA Litigation and Generic Entry Outlook for Vasotec
A generic version of VASOTEC was approved as enalapril maleate by HERITAGE PHARMA on August 22nd, 2000.
Summary for VASOTEC
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 6 |
| Patent Applications: | 3,513 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VASOTEC |
| DailyMed Link: | VASOTEC at DailyMed |
Recent Clinical Trials for VASOTEC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Brigham and Women's Hospital | Phase 4 |
| Novartis Pharmaceuticals | Phase 4 |
| University of Wisconsin, Madison | Phase 4 |
Pharmacology for VASOTEC
| Drug Class | Angiotensin Converting Enzyme Inhibitor |
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Paragraph IV (Patent) Challenges for VASOTEC
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VASOTEC | TABLET;ORAL | enalapril maleate | 018998 |
US Patents and Regulatory Information for VASOTEC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biovail Labs Intl | VASOTEC | enalaprilat | INJECTABLE;INJECTION | 019309-001 | Feb 9, 1988 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-002 | Dec 24, 1985 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-005 | Jul 26, 1988 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-001 | Dec 24, 1985 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-003 | Dec 24, 1985 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VASOTEC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Biovail Labs Intl | VASOTEC | enalaprilat | INJECTABLE;INJECTION | 019309-001 | Feb 9, 1988 | Start Trial | Start Trial |
| Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-002 | Dec 24, 1985 | Start Trial | Start Trial |
| Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-005 | Jul 26, 1988 | Start Trial | Start Trial |
| Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-003 | Dec 24, 1985 | Start Trial | Start Trial |
| Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-001 | Dec 24, 1985 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VASOTEC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Philippines | 24268 | Start Trial |
| Ireland | 792382 | Start Trial |
| Japan | H02131496 | Start Trial |
| Poland | 126126 | Start Trial |
| Canada | 1275349 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
